Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-15 are pending and examined on merits.
Priority
The filing date 11/04/2021 of the international application PCT/JP2021/04050 is the effective filing date of this 371 application.
Acknowledgment is made of applicant's claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) based upon an application filed in Japan on 11/04/2020.
Claim Objections
Claim 4 is objected to because of the following informalities: “DCO-K” should be spelled out at its first occurrence. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recite “performing further non-adhesion culture with the addition of prostaglandin E2 and OK432”.
Claim 2 recites “performing further culture with the addition of prostaglandin E2 and OK432 for 1 to 2 days”.
The two claims encompass two different culture methods (one broader than the other) in respective single claim.
A broad range or limitation, for example in claim 1, the performing step without prostaglandin E2 and OK432 (broader) or with a narrow range or limitation (with E2 and OK432) that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 2 recites the broad recitation the limitations before “further”, and the claim also recites the phrase after “further” which is the narrower statement of the limitation as related the conditions of the claimed culture. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For compact prosecution, the further step included each of the two claims would be interpreted as a performing occurs concurrently, not sequentially.
Claims 1, 11 and 4, 12 are confusing as related to whether there is any difference in scope between “DCO-K” in claim 4 and the culture medium described as “a serum-free medium containing a human platelet lysate (HPL), GM-CSF, and PEGylated interferon” in claim 1. The specification at Paragraph [0136] suggest they are the same. If they are the same, then claim 4 does not further limit the culture medium of claim 1. Claims 11 and 12 have the same problem. Not clear whether DCO-K is same as a serum-free medium containing a 1 to 10(v/v)% HPL.
For compact prosecution, they are interpreted to be the same material.
Claims 4 and 12 recite “DCO-K” but it is not clear whether it is a specific product sold by a specific company or a generic term as suggested by Paragraph [0136]
[0136] In the examples of the present invention, DCs prepared with the use of a medium supplemented with HPL and IFN are referred to as “HPL-IFN-DCs,” and DCs prepared with the use of a HPL-free medium supplemented with IFN are referred to as “IFN-DCs.”
[Example 1] Establishment of a Method for Separating Monocytes and a Method for Preparing IFN-DCs Using a Serum-Free Medium (DCO-K) with Optimized Additives (ABS or HPL)
For compact prosecution purpose, it is interested as a serum free medium.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Date of record (IDS #5, published between the foreign priority date and the effective filing date).
Date of record is considered as prior art, 1 year grace period not accorded because they were published by others. There are eight authors but only five inventors are listed in this applications.
As indicated on ISR, Date teaches the claimed invention as in claims 1-15. Note the entire article. Note more detailed claim analysis in 103 below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over US20180066229AI (“Shimodaira”, published 2018-03-08, IDS #1 filed 5/3/2023) in view of Svajger (2017, IDS #7 filed 5/3/2023).
Shimodaira teaches a method of preparing cytotoxic dendritic cells as shown in the right column below in claim 1.
Claim 1 of the instant application
Claim 1 of Shimodaira
A method for preparing cytotoxic dendritic cells from monocytes comprising
performing non-adhesion culture of monocytes separated from the peripheral blood with the use of a serum-free medium containing a human platelet lysate (HPL), GM-CSF, and PEGylated interferon a and performing further non-adhesion culture with the addition of prostaglandin E2 and OK432.
A method for preparing cytotoxic dendritic cells from monocytes comprising
subjecting monocytes which were isolated from the peripheral blood to non-adhesive culture in the presence of GM-CSF and pegylated interferon α and further conducting non-adhesive culture with the addition of prostaglandin E2 and OK432.
The difference between the instantly claimed invention and the teachings of Shimodaira shown by side by side above table is that Shimodaira does not teach a human platelet lysate (HPL) in its culture media.
However, Svajger teaches HPL is a successful alternative serum supplement for preparing monocyte derived dendritic cells. Note the title. Svajger also teaches (page 486, right column, the past paragraph) that there are many reasons to use HPL, lowering immunogenesity of dendritic cells when cultured in HPL as compared to culture using animal serum.
Regarding claim 2 further limiting the culture conditions of the base claim to the days of cultures to 2 to 5 days with a human platelet lysate (HPL), GM-CSF, and PEGylated interferon and 1 to 2 days with prostaglandin E2 and OK432, Shimodaira in claim 2 teaches a method of preparing cytotoxic dendritic cells for 2 to 5 days in the presence of GM-CSF and pegylated interferon α, non-adhesive culture is conducted for an additional 1 or 2 days with the addition of prostaglandin E2 and OK432.
Regarding claim 3, drawn to 1 to 10(v/v)% human platelet lysate (HPL), 100 U/ml to 10,000 U/ml GM- CSF, 500 ng/ml to 5 pg/ml PEGylated interferon a, 5 ng/ml to 50 ng/ml prostaglandin E2, and 5 pg/ml to 50 pg/ml OK432, Shimodaira in claim 3 teaches the same condition.
Regarding claims 4, 11 and 12, drawn to DCO-K is same as drawn to a serum-free medium containing a human platelet lysate (HPL) taught by Svajger.
Regarding claim 5, drawn to viability of the dendritic cells is 90% or higher and the yield, Shimodaira in claim 4 teaches the same viability.
Regarding claim 6, drawn to dendritic cells are positive for CD14, CD16, CD56, CD83, CD86, CCR7 (CD197), HLA-ABC, and HLA-DR, Shimodaira in claim 5 teaches the same dendritic cell having positive for the same markers.
Regarding claims 7-9, drawn to dendritic cells and pharmaceutical composition for cancer treatment, Shimodaira in claims 7-10 teaches dendritic cells and pharmaceuticals. When monocytes are cultured in the HPL culture media taught by Shimodaira and Svajger, it would produce the same products.
Regarding claim 10, drawn to a method of collecting adherent cells after removing non-adherent cells, Shimodaira teaches the following:
1. Preparation of Dendritic Cells
[0070] After informed consent was obtained, the peripheral blood mononuclear cells (PBMCs) were obtained from cancer patients via blood component collection (apheresis), and dendritic cells (DCs) were prepared using the obtained PBMCs as raw materials (Medical ethics approval number: 2107; date of approval: Sep. 4, 2012). With the use of IL-4 DCs obtained via culture of monocytes in the presence of the granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-4 (IL-4), OK432 (Picibanil®) prepared via treatment of a spontaneous mutant (Su strain) of group A Streptococcus pyogenes with penicillin, and prostaglandin E2 (PGE2), mature IL-4-OK DCs were prepared via a conventional adhesive culture technique. PBMCs were suspended in the AIM-V medium (Invitrogen Life Technologies) at the monocyte density of 2 to 4×10.sup.6 cells/ml, the cell suspension was inoculated into an adhesive cell culture dish (BD Primaria™, BD Bioscience), non-adherent cells were removed 30 minutes later, the medium was exchanged with the AIM-V medium supplemented with GM-CSF (50 ng/ml; Gentaur) and IL-4 (50 ng/ml; R&D Systems) on the following day, the adhered monocytes were cultured for 5 days, and immature IL-4 DCs were then recovered with the use of a scraper. For maturation, the cells were suspended in a fresh AIM-V medium containing 10 μg/ml of OK432 (streptococcal preparation, Chugai Pharmaceutical Co, Ltd, Tokyo, Japan) and 50 ng/ml of PGE2 (Daiichi Fine Chemical Co, Ltd, Toyama, Japan), and culture was conducted for an additional 16 to 24 hours to prepare dendritic cells. The dendritic cells prepared in such a manner are referred to as “IL-4-OK DCs.”
Regarding claims 11-12, drawn to a serum-free medium 1 1 to 10% HPL, Svajger teaches HPL based serum free media.
Regarding claim 13-15, Shimodaira (Fig. 11) teaches the dendritic cells have an antitumor activity.
Therefore, one of ordinary skill in the art would have been motivated to use HPL in method making cytotoxic dendritic cells with a reasonable expectation of success since Svajger teaches HPL is better to avoid potential nonspecific immunomodulatory effect when HPL is used in culture medium.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Misook Yu whose telephone number is (571)272-0839. The examiner can normally be reached M-Th, 7-5pm.
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/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641